Actively Recruiting
PIN in Combination With Anti-PD1 in Previously Treated Primary Hepatocellular Carcinoma
Led by Chinese PLA General Hospital · Updated on 2025-06-22
25
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
C
Changping Laboratory
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this single-center,open-label, phase I study, the safety and efficacy of PIN in combination with programmed cell death protein antibody (anti-PD1) therapeutic regimen will be evaluated in patients with refractory primary advanced hepatocellular carcinoma(HCC) . A total of 25 to 30 patients are planned to be enrolled and receive PIN plus anti-PD1 combined treatment. It aims to: 1).assess the safety and antitumor effects of the above combined treatment regimen. 2).detect the dynamic changes and molecular characteristics of PIN-induced CD8+ T cells with special phenotype in peripheral blood (PB) and transformation of tumor microenvironment (TME) after the treatment with PIN. 3).evaluate the immunological or clinical predictive biomarkers for toxicity and efficacy.
CONDITIONS
Official Title
PIN in Combination With Anti-PD1 in Previously Treated Primary Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive
- ECOG performance status of 0 to 2 with estimated life expectancy over 3 months
- Histologically or clinically confirmed advanced or metastatic hepatocellular carcinoma refractory to or intolerant of standard therapies
- At least one measurable lesion per RECIST 1.1 criteria at baseline
- At least one injectable lesion of 10 mm or larger in skin, mucous membrane, subcutaneous tissue, lymph node, or visceral organ
- Willingness to undergo tumor rebiopsy during the study
- Barcelona Clinic Liver Cancer (BCLC) stage C or lower
- Adequate organ function including specified blood counts and liver, kidney, heart function
- Effective antiviral treatment and monitoring for hepatitis B if infected, allowance for hepatitis C infection with conditions
- Completed previous treatments at least 4 weeks prior with recovery to grade 1 or less toxicity (except certain minor toxicities)
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during and one year after treatment
- Voluntary informed consent
You will not qualify if you...
- Use of corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressants within 14 days before enrollment
- Active central nervous system disease or recent brain metastases not stable for at least 4 weeks
- Uncontrolled or severe infections requiring intravenous antimicrobials
- Serious medical or psychiatric conditions limiting study compliance
- Major surgery or trauma within 28 days before enrollment or incomplete recovery from side effects
- Recent treatment with cytotoxic drugs, monoclonal antibodies, immunotherapy within 4 weeks or 5 half-lives
- Radiotherapy within 3 months before enrollment
- Primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy
- Uncontrollable pleural effusion or ascites
- Other cancers within 3 years except certain treated early-stage cancers
- Positive HIV or AIDS diagnosis
- Prior organ or stem cell transplant
- Allergy or intolerance to study drugs
- Pregnant or breastfeeding women
- Participation in other clinical trials within 4 weeks
- Any other reasons deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China
Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang Liu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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